CDSCO Panel grants Novartis Protocol Amendment proposal for Remibrutinib study in Relapsing Multiple Sclerosis
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Novartis protocol amendment proposal for clinical trial protocol titled, "Efficacy and safety of Remibrutinib compared to Teriflunomide in participants with relapsing multiple sclerosis".
This came after the drug maker Novartis presented protocol amendment version 03 dated 20 February 2023 protocol no. CLOU064C12301. The study aims to compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis.
The study CLOU064C12301 consists of an initial Core Part (CP) (maximum duration per participant of up to 30 months), followed by an Extension Part (EP, of up to 5 years duration) for eligible participants.
The Core Part is a randomized, double-blind, double-dummy, active comparator-controlled, fixed-dose, parallel-group, multi-center study in approximately 800 participants with relapsing multiple sclerosis (RMS).
The Extension Part is an open-label, single-arm, fixed-dose design in which eligible participants are treated with remibrutinib for up to 5 years.
A second study of identical design (CLOU064C12302) will be conducted simultaneously. Both studies will be conducted globally and data from the two studies will be pooled for some of the endpoints.
Remibrutinib belongs to a group of medicines called Bruton's tyrosine kinase (BTK) inhibitors. Bruton's tyrosine kinase is an enzyme that is essential for the survival and activation of B-cells.
Remibrutinib blocks BTK and prevents the release of histamine that causes itchy hives (wheals) and/or deep tissue swelling (angioedema). The mechanism of action of remibrutinib promotes rapid covalent binding to BTK targets and fast clearance of unbound drug thus preventing extended periods of drug exposure.
At the recent SEC meeting for Neurology and Psychiatry held on 18th and 19th January 2024, the expert panel reviewed the proposal presented by the drug major Novartis for the protocol amendment version 03 dated 20 February 2023 protocol no. CLOU064C12301.
After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.
